1. Field of the Invention
This invention relates generally to connectors used in the medical field, and more particularly to a plug and sealing system for medical bayonet connectors and drug infusion ports that will prevent contamination of the interior surfaces of the female bayonet collar from environmental contaminants and engage a self-sealing plug or membrane in the female bayonet collar in a sealing relation, before or after penetration by a puncturing needle, to prevent leakage and spreading of aerosols or vapor.
2. Brief Description of the Prior Art
Drugs for treating cancer, cytotoxic drugs, are very beneficial, however, they may cause serious problems for the medical personnel handling them. When medical personnel work with chemo and/or cytotoxic drugs, they rely on gowns and gloves to prevent contamination and safety cabinets or safety hoods to substantially filter the surrounding air in the environment of the cabinet or hood. However, new evidence has shown that cytotoxic drugs vaporize at room temperature, i.e. safety cabinets cannot protect the personnel from the dangerous vapor. Also, by contamination the drugs are found under gloves and gowns.
Those at risk to exposure include pharmacy technicians who prepare the drugs and oncology nurses that administer them to the patients and take care of the waste handling. The drugs are usually delivered to the pharmacy either as a powder or in solution. A pharmacy technician dissolves the powder in the vial and loads the solution into syringes or infusion sets, ready to be administered. The oncology nurse then administers the drug to the patient and discards the waste products.
Scientific studies have shown contamination by cytotoxic drugs on working trays, on floors, on vials and on outside surfaces of safety cabinets. Contamination is even seen on floors outside the preparation room. Once established, the contamination is almost impossible to remove or get rid of. Several studies have also shown that cytotoxic drugs are frequently found in the urine of personnel preparing and administrating them, and among personnel who are not even in contact with the vials. Some of the serious complications due to exposure to cytotoxic drugs include liver damage, leukemia, non-Hodgkin""s lymphoma, skin cancer, miscarriages, malformations and children with low birthweight.
Due to the concern about the level of environmental contamination, many hospitals are implementing a closed system for the preparation and administration of cytotoxic drugs. One such system is known as PhaSeal(copyright), manufactured by Carmel Pharma AB of Sweden, and commercially available through its U.S subsidiary, Carmel Pharma Inc., of Shelton, Connecticut. PhaSeal(copyright) is a completely sealed system for preparation, administration and waste handling. The PhaSeal(copyright) system was developed by Bengt Gustavsson, and some of the components are disclosed in U.S. Pat. Nos. 4,564,054, 4,673,404, and 4,785,859. The PhaSeal(copyright) system utilizes two key features to transfer drugs; a double membrane system, and a pressure equalization technique.
The PhaSeal(copyright) xe2x80x9cProtectorxe2x80x9d is a vial transfer adapter cover having a bottom end that is fastened to a drug vial and has a built-in expansion chamber to equalize the pressure when diluting the drug, injecting air into the vial, or aspirating the drug. The expansion chamber significantly reduces the likelihood of vapor and aerosol leakage during preparation.
The PhaSeal(copyright) xe2x80x9cConnector Luer Lockxe2x80x9d is a connector that attaches to a patient""s I.V. tubing to allow a sealed drug transfer for I.V. push therapy. The PhaSeal(copyright) xe2x80x9cInfusion Adapterxe2x80x9d is a non-vented intravascular administration connector that allows a sealed drug transfer directly into I.V. bags.
The PhaSeal(copyright) xe2x80x9cInjector Luerxe2x80x9d is drug transfer needle device having an encapsulated cannula that is permanently locked onto a syringe using a Luer or Luer Lock fitting. The opposed end of the cannula xe2x80x9cInjector Luerxe2x80x9d has a male bayonet fitting with an elastomeric A self-sealing membrane at the tip end. Sealed transfer can be made via the xe2x80x9cInjector Luerxe2x80x9d in both the preparation and administration. The expansion chamber significantly reduces the likelihood of vapor and aerosol leakage during preparation.
Each of the components described above utilizes the xe2x80x9cdouble membranexe2x80x9d system. The xe2x80x9cProtectorxe2x80x9d vial cover, the xe2x80x9cConnector Luer Lockxe2x80x9d and the xe2x80x9cInfusion Adapterxe2x80x9d each have a female bayonet connector fitting. The female bayonet cavity has a hollow tubular side wall and a bottom wall with an elastomeric self-sealing membrane installed therein through which a needle can be passed. The bottom end of the xe2x80x9cInjector Luerxe2x80x9d encapsulated cannula has a male bayonet fitting with a self-sealing membrane at the tip end, and is designed to be received in the female bayonet connector fitting of either of the xe2x80x9cProtectorxe2x80x9d vial cover, the xe2x80x9cConnector Luer Lockxe2x80x9d or the xe2x80x9cInfusion Adapterxe2x80x9d, such that the elastomeric self-sealing membranes of the male and female components are resiliently engaged face to face. Transfer is made via a specially cut injection cannula. When the components are separated after transfer, the membranes act as tight seals to prevent leakage and spreading of aerosols or vapor.
The closed system for the preparation and administration of cytotoxic drugs, as described above, is a significant improvement, and is effective provided that the drug is a one-time dose, where the remainder of drug in the vial is discarded, or that additional medications are not added to the I.V. bag before infusion to the patient. However, in many cases the cytotoxic drugs, themselves, may become contaminated due to the manner in which they are handled before and after infusion.
In U.S. hospitals, cytotoxic drugs must be taken out of the safety cabinet or safety hood and transported to another location to be checked by a registered pharmacist. In some instances, a vial containing a remainder of the drug may be placed in storage for future use. In many instances, additional medications are required to be added to the I.V. bag before infusion to the patient. In these situations the female bayonet cavity of the connectors are only sealed by the small elastomeric self-sealing membrane in its bottom wall, and the interior surfaces of the tubular cavity and outer face of the self-sealing membrane are exposed to the environment and can become contaminated. This can also cause contamination of the cytotoxic drug when the male bayonet fitting is installed into the contaminated female bayonet connector, and transfer is made via the injection cannula.
The present invention is distinguished over the prior art in general and these patents in particular by a plug and sealing system for medical bayonet connectors and drug infusion ports of the type having an interior self-sealing element, wherein a male plug removably installed in the female collar portion of the connector, before or after penetration of the self-sealing element by a puncturing needle, has a shank portion the fits the inner surfaces of the collar portion side wall to provide a substantial sealing relation therebetween to prevent contamination of the interior surfaces of the collar portion from environmental contaminants. The plug has a bottom end that is resiliently engaged on an outer face of the self-sealing element, and a pair of lugs that are resiliently biased against a top wall of diametrically opposed apertures in the side wall of the collar portion to maintain the bottom end in a firm sealing relation with the self-sealing element to prevent leakage and spreading of aerosols and vapor.
It is therefore an object of the present invention to provide a plug for medical bayonet connectors and drug infusion ports that will prevent contamination of the interior surfaces of the female bayonet collar from environmental contaminants.
It is another object of this invention to provide a plug for medical bayonet connectors and drug infusion ports that will engage a self-sealing plug or membrane in the female bayonet collar portion the connector in a sealing relation, before or after penetration by a puncturing needle, to prevent leakage and spreading of aerosols or vapor.
Another object of this invention is to provide a plug for medical bayonet connectors and drug infusion ports that can be quickly and easily installed in the female bayonet collar portion of a vial transfer adapter attached to a drug vial, an intravascular administration connector attached to an I.V. bag, or a connector that attaches to a patient""s I.V. tubing.
Another object of this invention is to provide a medical bayonet connector sealing system that will prevent contamination of the interior surfaces of the female bayonet collar from environmental contaminants and engage a self-sealing plug or membrane in the female bayonet collar in a sealing relation, before or after penetration by a puncturing needle, to prevent leakage and spreading of aerosols or vapor.
A further object of this invention is to provide a plug for medical bayonet connectors and drug infusion ports that will not become accidentally loosened or dislodged from the connector.
A still further object of this invention is to provide a plug for medical bayonet connectors and drug infusion ports that is simple in construction, inexpensive to manufacture, rugged and reliable in use, and disposable after use.
Other objects of the invention will become apparent from time to time throughout the specification and claims as hereinafter related.
The above noted objects and other objects of the invention are accomplished by the present plug and sealing system for medical bayonet connectors and drug infusion ports of the type having an interior self-sealing element, wherein a male plug removably installed in the female collar portion of the connector, before or after penetration of the self-sealing element by a puncturing needle, has a shank portion the fits the inner surfaces of the collar portion side wall to provide a substantial sealing relation therebetween to prevent contamination of the interior surfaces of the collar portion from environmental contaminants. The plug has a bottom end that is resiliently engaged on an outer face of the self-sealing element, and a pair of lugs that are resiliently biased against a top wall of diametrically opposed apertures in the side wall of the collar portion to maintain the bottom end in a firm sealing relation with the self-sealing element to prevent leakage and spreading of aerosols and vapor.